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Individual Sections
Overview and Control Document - Version History and Notice of Changes (Download) 2018-11-09465.39 KB
Table of Contents - Current Sections (Download) 2018-11-09372.22 KB
Section 01: Introduction (Download) 2018-11-09264.82 KB
Section 02: Documentation Requirements (Download) 2018-11-09422.57 KB
Section 03: Accrual and Retention (Download) 2018-11-09506.89 KB
Section 04: Informed Consent (Download) 2018-11-09516.08 KB
Section 05: Study Procedures (Download) 2018-11-09698.1 KB
Section 06: Behavioral Measures (Download) 2018-11-09861.67 KB
Section 07: Study Product Considerations for Non-Pharmacy Staff (Download) 2018-11-09766.87 KB
Section 08: Clinical Considerations (Download) 2018-11-09656.57 KB
Section 09: Adverse Event Reporting and Safety Monitoring (Download) 2018-11-09699.97 KB
Section 10: Laboratory Considerations (Download) 2018-11-09947.43 KB
Section 11: Counseling Procedures (Download) 2018-11-09424.9 KB
Section 12: Data Collection (Download) 2018-11-09710.38 KB
Section 13: Data Communiqués (Download) 2018-11-09209.64 KB
Section 14: Study Reporting Plan (Download) 2018-11-09572.2 KB